Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00122

2 Trial Registration Date

2007-04-12

i Registration Status

Retrospective

3 Secondary IDs

4 Source(s) of Funding

Research Grant Council Grant CUHK 4317/04

5 Primary Sponsor

Nil

6 Secondary Sponsor

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Adrian Wong

ii Address

iii Phone

adrianwong@cuhk.edu.hk

iv Email

email

v Affiliation

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Ka Sing Wong

ii Address

iii Phone

ks-wong@cuhk.edu.hk

iv Email

email

v Affiliation

vi Country

9 Official Scientific Title of the Study

Effect of Multivitamins Supplementation on the Progression of Cerebral White Matter Changes and Cognitive Impairment in Chinese Stroke Patients with Moderate to Severe Leukoaraiosis

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

VITATOPS MRI Substudy

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2004-05-04

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Stroke with Moderate to Severe Leukoaraiosis

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Daily folate 2mg + Vitamins B6 25mg + B12 500 microgram

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

2 years

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Placebo

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion Criteria All subjects presenting within 7 months of a stroke or TIA are eligible provided they agree to take study medication, be available for follow-up and provide written informed consent. Exclusion Criteria Taking vitamins on medical advice Independent self-medication with vitamin supplements containing B6, B12 or folate Taking methotrexate for any reason Pregnancy or women of child bearing potential who are at risk of pregnancy Limited (less than two years) life expectancy Auditory, visual, or language impairment, severe enough to prevent cognitive assessment Pacemaker or other contraindication to MRI scanning

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2004-09-01

21 Target Sample Size

100

22 Recruitment Status

Complete

23 Primary Outcome

Stroke (ischemic or hemorrhagic), myocardial infarction or death from any vascular cause

24 Secondary Outcome

Transient ischemic attack, depression, dementia, unstable angina, revascularization procedures of the coronary, cerebral or peripheral circulations

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2009-11-23

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

None

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Trial History Detail on 2007-11-12